Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00743015
First received: August 27, 2008
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

The general aim is to evaluate the relative oral bioavailability of BI 44370 TA tablets during and between migraine attacks as well as Safety, Tolerability and Pharmacokinetic


Condition Intervention Phase
Migraine Disorders
Drug: BI 44370 TA tablet
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: Relative Bioavailability Following Single Oral Administration of 200 mg of BI 44370 During and Between Migraine Attacks in Male and Female Migraine Patients. An Open-label, Fixed-sequence, Two-period Study With Intraindividual Comparison

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Cmax (maximum concentration of BI 44370 BS in plasma) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • AUC0-2 (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 to 2 h after drug administration) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • AUC0-∞ (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC0-tz (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • AUCt1-t2 (Area under the concentration-time curve of BI 44370 BS in plasma over the time interval t1 to t2) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • λz (terminal rate constant in plasma) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • t1/2 (terminal half-life of BI 44370 BS in plasma) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • MRTp.o. (mean residence time of BI 44370 BS in the body after p.o. administration) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • CL/F (Apparent clearance of BI 44370 BS in plasma after extravascular administration) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Ae0-12 (amount of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • fe0-12 (fraction of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • CLR,0-12 (renal clearance of BI 44370 BS from time point 0 - 12 h after drug administration) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Changes from baseline in Physical examination [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Changes from baseline in Vital signs: Blood pressure (BP) and pulse rate (PR) [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Changes from baseline in 12-lead electrocardiogram (ECG) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Occurrence of Adverse events (AEs) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Assessment of tolerability by investigator [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Number of participants with abnormalities in clinical laboratory parameters [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: September 2008
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male and female migraine patients (age 18 to 65 years) with or without aura, diagnosed according to IHS criteria.
  • Established migraine diagnosis for >= 1 year.
  • Age at migraine onset <= 50 years.
  • Well documented (for >= 3 months) retrospective history of migraine with headache of moderate to severe intensity and with an attack duration of at least 6 hours and migraine frequency of 2-8 times / month
  • Other forms of headache are permitted if they on average occur on not more than 10 days / month and if the patient is able to differentiate migraine headache from other forms of headache.
  • Patient has provided written informed consent in accordance with ICH-GCP and local legislation.
  • Patient is in general good health based om screening assessment

Exclusion Criteria:

  • Women of child-bearing potential without an adequate method of contraception
  • Any woman of child-bearing potential not having a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline
  • Breastfeeding women
  • Males not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilization, IUD [intrauterine device]) during the whole study period from the time of the first intake of study drug until three months after the last intake.
  • History of hemiplegic, ophthalmoplegic, or basilar migraine or cluster headache.
  • History of treatment resistant migraine attacks, defined as a lack of response to a range of commonly used acute anti-migraine compounds.
  • History of , clinical evidence for, or screening/baseline findings suggestive of significant medical disorders (e.g. cardiovascular, peripheral vascular, hepatic, respiratory, haematological, renal, gastrointestinal, immunological, metabolic, hormonal, neurological or psychiatric disorders)
  • Smokers ... (cont.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743015

Locations
Belgium
1246.21.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium
Germany
1246.21.49001 Boehringer Ingelheim Investigational Site
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00743015     History of Changes
Other Study ID Numbers: 1246.21, EudraCT 2008-001356-42
Study First Received: August 27, 2008
Last Updated: October 31, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 10, 2014